Effect of Research Participation Vs. Usual Clinical Treatment on Pain in Patients with Musculoskeletal Disorders: Protocol for a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,850
- 试验地点
- 1
- 主要终点
- The Brief Pain Inventory short form
研究概览
简要总结
This study explores the effects on pain, function and illness perceptions, of participating in clinical research versus being treated with standard care in patients with musculoskeletal disorders.
详细描述
Musculoskeletal (MSK) disorders are a major burden on individuals, health systems, and social care systems. Increases in life expectancy and ageing populations are expected to make MSK disorders one of the leading causes of disability by the year 2020.
When faced with a potentially life changing diagnosis of a chronic disease, people (in general) develop an organized pattern of perceptions about their condition, and how it impacts their lives and often, the essentially same stressful event may cause significant variations in perceptions. These different perceptions and coping strategies might affect the way the individual chooses to handle the disease and seek health care assistance, which altogether eventually may affect the course of the illness.
Study participation besides reassurance, could be hypothesized to induce beneficial outcomes for the patients, but is it reasonable to expect an effect of study participation regardless of study intervention, design and group allocation? And is an eventual effect mainly derived from the intervention or from the participants being a selected group?
It remains to be clarified, whether and how study participation affects the individual's treatment effect and perceptions of the illness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Diagnosed with a musculoskeletal disorder
- •Currently enrolled in a health research study hosted by the outpatient osteoarthritis clinic at Frederiksberg Hospital OR Being treated in the outpatient osteoarthritis clinic at Frederiksberg Hospital and not participating in a health research study
- •Reads and speaks Danish
- •Consents to participation in this survey
排除标准
- •We have no formal exclusion criteria
结局指标
主要结局
The Brief Pain Inventory short form
时间窗: At baseline and end of study (<=1 year)
The BPI measures the intensity of pain experienced within the last 24 hours and how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. In this study we will use the short version (BPI-SF). The BPI-SF is based on numerical rating scales (0-10). The arithmetic mean of the four severity items can be used as measures of pain severity. A lower score indicates less pain interference
次要结局
- PainDETECT questionnaire(At baseline and end of study (<=1 year))
- Widespread Pain Index(At baseline and end of study (<=1 year))
- The Brief Illness Perception Questionnaire(At baseline and end of study (<=1 year))
- Health Assessment Questionnaire (Disability)(At baseline and end of study (<=1 year))
- EQ-5D-3L(At baseline and end of study (<=1 year))
研究者
Marius Henriksen
PT, PhD, Professor
Frederiksberg University Hospital